NCT01420016

Brief Summary

The objective of this project is to develop and implement sophisticated point-of-care Electronic Health Record (EHR)-based clinical decision support that (a) identifies and (b) prioritizes all available evidence-based treatment options to reduce a given patient's cardiovascular risk (CVR). After developing the EHR-based decision support intervention, the investigators will test its impact on CVR, the components of CVR, in a group randomized trial that includes 18 primary care clinics, 60 primary care physicians, and 18,000 adults with moderate or high CVR. This approach, if successful, will (a) improve chronic disease outcomes and reduce CVR for about 35% of the U.S. adult population, (b) maximize the clinical return on the massive investments that are increasingly being made in sophisticated outpatient EHR systems, and (c) provide a model for how to use EHR technology support to deliver "personalized medicine" in primary care settings

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,914

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
Completed

Started Aug 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 19, 2011

Completed
1 year until next milestone

Study Start

First participant enrolled

August 20, 2012

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2014

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

September 21, 2018

Completed
Last Updated

September 21, 2018

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

January 17, 2011

Results QC Date

August 14, 2017

Last Update Submit

September 17, 2018

Conditions

HypertensionHyperlipidemiaDiabetesSmokingCardiovascular Risk FactorCardiovascular Diseases

Keywords

Cardiovascular riskClinical Decision SupportElectronic Health RecordsPrimary CareQuality of Care

Outcome Measures

Primary Outcomes (1)

  • Predicted Annual Rate of Change in 10-year Risk of Fatal or Nonfatal Heart Attack or Stroke

    Ten year cardiovascular risk was calculated at each post index visit from the most recent clinical and laboratory values in the EMR. The Framingham lipid equation was used when a lipid value was available in the previous 5 years; otherwise the Framingham BMI equation was used. The primary outcome was the annualized rate of change (slope) in 10-year CVR, estimated for each treatment group from the time and time-by-treatment parameters of a mixed regression model which predicted post-index CVR values from time elapsed since index, treatment group and the time by treatment interaction.

    Index to 14 months post index

Study Arms (2)

Prioritized Clinical Decision Support

ACTIVE COMPARATOR

The Prioritized Clinical Decision Support (CDS) intervention is a protocol driven CDS system linked within the EMR that identifies patients with high cardiovascular risk and provides tailored, prioritized decision support to the provider and patient at the point of care. The CDS was printed at intervention sites. It i) compiled most recent lab data (A1c, SBP, and LDL), BMI, smoking status, and aspirin use, (ii) calculated a 10-year risk for stroke or heart attack, (iii) prioritized clinical domains based on the absolute risk reduction for each component, (iv) compiled information related to renal and liver function, creatine kinase level, and previous diagnoses (CHF, CVD, DM), and (v) provided recommendations for intensification of therapy for A1c, SBP and/or LDL if not at goal.

Other: Prioritized Clinical Decision Support

Usual Care

NO INTERVENTION

Providers in the usual care arm did not have access to the prioritized clinical decision support tool.

Interventions

Prioritized Clinical Decision SupportOTHER

Eighteen primary care clinics were blocked on size and on patient characteristics. Each clinic was randomly assigned to one of 2 study arms. All consenting PCPs were allocated to the study arm that their clinic was assigned to and the estimated 400 eligible adults with 10-year CVR \>= 10% under the care of each consenting physician were allocated to the same treatment arm as their PCP.

Also known as: Cardiovascular Wizard, CV Wizard
Prioritized Clinical Decision Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Practicing general internist or family physician at HealthPartners Medical Group (HPMG)
  • Provide ongoing care for 200 or more adult patients with 10 year CVR \>=10%

You may not qualify if:

  • PCP not practicing in HPMG clinic
  • Patient age greater than 80 years
  • Patient Charlson comorbidity score greater than 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (11)

  • Wolfson J, Vock DM, Bandyopadhyay S, Kottke T, Vazquez-Benitez G, Johnson P, Adomavicius G, O'Connor PJ. Use and Customization of Risk Scores for Predicting Cardiovascular Events Using Electronic Health Record Data. J Am Heart Assoc. 2017 Apr 24;6(4):e003670. doi: 10.1161/JAHA.116.003670.

    PMID: 28438733BACKGROUND

  • O'Connor PJ, Sperl-Hillen JM, Fazio CJ, Averbeck BM, Rank BH, Margolis KL. Outpatient diabetes clinical decision support: current status and future directions. Diabet Med. 2016 Jun;33(6):734-41. doi: 10.1111/dme.13090.

    PMID: 27194173BACKGROUND

  • O'Connor PJ, Sperl-Hillen JM, Margolis KL, Kottke TE. Strategies to Prioritize Clinical Options in Primary Care. Ann Fam Med. 2017 Jan;15(1):10-13. doi: 10.1370/afm.2027. Epub 2017 Jan 6. No abstract available.

    PMID: 28376456BACKGROUND

  • Vock DM, Wolfson J, Bandyopadhyay S, Adomavicius G, Johnson PE, Vazquez-Benitez G, O'Connor PJ. Adapting machine learning techniques to censored time-to-event health record data: A general-purpose approach using inverse probability of censoring weighting. J Biomed Inform. 2016 Jun;61:119-31. doi: 10.1016/j.jbi.2016.03.009. Epub 2016 Mar 16.

    PMID: 26992568BACKGROUND

  • Wolfson J, Bandyopadhyay S, Elidrisi M, Vazquez-Benitez G, Vock DM, Musgrove D, Adomavicius G, Johnson PE, O'Connor PJ. A Naive Bayes machine learning approach to risk prediction using censored, time-to-event data. Stat Med. 2015 Sep 20;34(21):2941-57. doi: 10.1002/sim.6526. Epub 2015 May 18.

    PMID: 25980520BACKGROUND

  • O'Connor PJ, Desai JR, Butler JC, Kharbanda EO, Sperl-Hillen JM. Current status and future prospects for electronic point-of-care clinical decision support in diabetes care. Curr Diab Rep. 2013 Apr;13(2):172-6. doi: 10.1007/s11892-012-0350-z.

    PMID: 23225213BACKGROUND

  • Gilmer TP, O'Connor PJ, Sperl-Hillen JM, Rush WA, Johnson PE, Amundson GH, Asche SE, Ekstrom HL. Cost-effectiveness of an electronic medical record based clinical decision support system. Health Serv Res. 2012 Dec;47(6):2137-58. doi: 10.1111/j.1475-6773.2012.01427.x. Epub 2012 May 11.

    PMID: 22578085BACKGROUND

  • O'Connor PJ, Sperl-Hillen JM, Rush WA, Johnson PE, Amundson GH, Asche SE, Ekstrom HL, Gilmer TP. Impact of electronic health record clinical decision support on diabetes care: a randomized trial. Ann Fam Med. 2011 Jan-Feb;9(1):12-21. doi: 10.1370/afm.1196.

    PMID: 21242556BACKGROUND

  • O'Connor P. Opportunities to Increase the Effectiveness of EHR-Based Diabetes Clinical Decision Support. Appl Clin Inform. 2011 Aug 31;2(3):350-4. doi: 10.4338/ACI-2011-05-IE-0032. Print 2011.

    PMID: 23616881BACKGROUND

  • Sperl-Hillen J, Margolis K, Crain L. Risk and Benefit Information and Use of Aspirin. JAMA Intern Med. 2017 Feb 1;177(2):291. doi: 10.1001/jamainternmed.2016.7988. No abstract available.

    PMID: 28166337BACKGROUND

  • Sperl-Hillen JM, Crain AL, Margolis KL, Ekstrom HL, Appana D, Amundson G, Sharma R, Desai JR, O'Connor PJ. Clinical decision support directed to primary care patients and providers reduces cardiovascular risk: a randomized trial. J Am Med Inform Assoc. 2018 Sep 1;25(9):1137-1146. doi: 10.1093/jamia/ocy085.

    PMID: 29982627RESULT

MeSH Terms

Conditions

HypertensionHyperlipidemiasDiabetes MellitusSmokingCardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism DisordersEndocrine System DiseasesBehavior

Limitations and Caveats

Because this study was conducted at a single, relatively high-performing medical group, generalizability of results to other care delivery systems or patient populations is uncertain.

Results Point of Contact

Title
Dr. Patrick O'Connor
Organization
HealthPartners Institute
patrick.j.oconnor@healthpartners.com
952-967-5034

Study Officials

  • Patrick J O'Connor, MD, MPH, MA

    HealthPartners Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2011

First Posted

August 19, 2011

Study Start

August 20, 2012

Primary Completion

August 19, 2014

Study Completion

August 19, 2014

Last Updated

September 21, 2018

Results First Posted

September 21, 2018

Record last verified: 2015-02

Data Sharing

IPD Sharing
Will not share